MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2); TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of reproducibly reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2) results for one patient which were discordant relative to clinical expectation.Siemens is investigating.
Event or Problem Description
The customer reports observation of reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2) results which were discordant relative to clinical expectation when using ahbs2 lot: 176.A 31-year-old female patient undergoing treatment for herpes produced reproducible reactive atellica im ahbs2 results despite lack of vaccination or administration of gamma globulins.The same patient had tested negative on (b)(6) 2025.When tested on (b)(6), a strongly reactive result was obtained.This was questioned, and the sample was re-tested two days later on an alternate atellica im analyzer, with essentially the same result.The reactive results for this patient are considered erroneous.There are no allegations of any adverse patient consequences in association with the observed discordance.
Additional Manufacturer Narrative
Following issuance of a supplemental report on 14-nov-2025, additional information was received in connection with this problem investigation.Additional testing was performed.The patient sample was evaluated for the presence of heterophilic antibodies (hbt) and non-specific antibodies (nabt) using scantibodies block tubes.Results did not indicate interference attributable to hbt or nabt as the cause of the discordant atellica im ahbs2 result.The investigation conclusion and coding are unchanged.Based on the available evidence, the discordant result is most consistent with a sample-specific interferent of unknown origin.This conclusion is supported by elevated initial results not corroborated by additional infectious disease testing, negative interference testing (hbt and nabt), and inconsistency with previously generated patient results.The customer remains operational, and no systemic product problem was identified.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of reactive atellica im anti-hepatitis b surface antigen 2 (ahbs2) results which were discordant relative to clinical expectation.Mdr was initially submitted on 22-oct-2025.Update, 13-nov-2025: siemens has concluded the investigation.A strongly reactive ahbs2 result was obtained for a patient who had previously tested negative; the result was reproducible upon repeat testing.The patient had not been vaccinated nor treated with gamma globulins.Siemens reviewed the available information.Reagent issues were ruled out as quality control (qc) results were within expected ranges, and no issues were identified for any other samples.Assay calibration data showed valid calibration prior to the discordant measurements.The patient samples was not tested for the presence of heterophilic antibodies (using hbt or nabt treatment), and samples were depleted and unavailable for additional testing.Consequently, siemens is unable to investigate further.It is noted that the assay¿s instructions for use (ifu), under clinical sensitivity and specificity, states the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88%, so a certain number of false positive results can be expected.Based on the available information, a definitive cause for the discordance could not be identified, but the observation is consistent with a sample-specific interferent of unknown origin.The customer is operational, and no systemic product problems were identified.Note: in section h6, the codes for investigation findings and investigation conclusions were updated.

• Brand Name: ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)
• Common Device Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney st.; registration #1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 23357129
• Report Number: 1219913-2025-00192
• Device Sequence Number: 8861014
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: (01)00630414597836(10)05988176(17)270130
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P100039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10995453
• Device Lot Number: 05988176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 12/08/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/14/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female